Sea & Ski Sport Lotion SPF 50

GENERAL PROTECTION- avobenzone,octocrylene,octisalate,homosalate,octinoxate lotion
Cross-Brands Manufacturing, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GENERAL PROTECTION
avobenzone,octocrylene,octisalate,homosalate,octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71153-2004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71153-2004-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/23/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/23/2016

Labeler - Cross-Brands Manufacturing, LLC (080319350)

Name	Address	ID/FEI	Business Operations
Establishment
Cross-Brands Manufacturing, LLC		080319350	label(71153-2004) , manufacture(71153-2004)